Cleared Traditional

K933908 - MEDRAD CT CUSTOM CONVENIENCE KIT

K933908 is the FDA 510(k) clearance for MEDRAD CT CUSTOM CONVENIENCE KIT by Medrad, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K933908 · Medrad, Inc. · Cardiovascular device
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Feb 1994
Decision
198d
Days
Class 2
Risk

K933908 is an FDA 510(k) clearance for the MEDRAD CT CUSTOM CONVENIENCE KIT. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrad, Inc. devices

Submission Details

510(k) Number K933908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1993
Decision Date February 25, 1994
Days to Decision 198 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K933908.
MEDRAD SPECTRIS MR INJECTOR
K935668 · Medrad, Inc. · Sep 1995
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
K951802 · Scimed Life Systems, Inc. · Jul 1995
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
K934086 · Medrad, Inc. · Jun 1995
MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
K924116 · Medrad, Inc. · Jan 1993
MEDRAD MCT-PLUS INJECTOR
K913624 · Medrad, Inc. · Jul 1992
TRAC-WRIGHT SYSTEM, MODEL TW2
K910594 · Dow Corning Wright · Sep 1991